Recall Z-0955-2025— IsoTis OrthoBiologics, Inc.

Name: FDA recall Z-0955-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-27

Class II · Ongoing

Class II FDA medical device recall by IsoTis OrthoBiologics, Inc., initiated 2024-11-27. It names one FDA 510(k) clearance: K242273. Product: OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.. Reason: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray..

Recalling firm: IsoTis OrthoBiologics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K242273 — Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation·cleared 2024-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

Reason for recall

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

Data sourced from openFDA. This site is unofficial and independent of the FDA.